Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

Loma Linda University (LLU)

Status: Active, not recruiting

Conditions: Kidney Failure

Treatments: Procedure: Kidney Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04605679

5200098

Details and patient eligibility

About

To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age 18 and older
• English and Spanish speaking patients
• Active on the waiting list for kidney transplantation
• Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
• HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
• Willing and able to provide written informed consent

Exclusion criteria

• Participants co-infected with HIV
• Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
• Known allergies or hypersensitivity to DAA or RBV
• Pregnancy and/or actively breastfeeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Recipient of HCV positive kidney graft

Experimental group

Description:

A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).

Treatment:

Procedure: Kidney Transplantation